Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Amerisource Health Services LLC
- Reason for Recall:
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Product Codes/Lot Numbers:
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0537-2026
Related Recalls
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Amerisource Health Services
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.
Amerisource Health Services
Failed tablet specifications.
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.